Efficacy and Safety Study of a Sublingual Immunotherapy Solution to Treat Patients Suffering From Birch Pollen Allergic Rhinoconjunctivitis
- Conditions
- HypersensitivityAllergic RhinitisAllergic ConjunctivitisSeasonal Allergy
- Interventions
- Biological: PlaceboBiological: Birch pollen allergen extract
- Registration Number
- NCT01731249
- Lead Sponsor
- Stallergenes Greer
- Brief Summary
The purpose of this 2-year study is to assess the sustained clinical efficacy and safety of 300 IR/day of a sublingual solution of birch pollen allergen extract starting 4 months prior to the birch pollen season and continuing over the birch pollen season compared with placebo for reduction of rhinoconjunctivitis-related symptoms and anti-allergy medication usage.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 574
- Symptomatic birch pollen-related allergic rhinoconjunctivitis for at least the previous 2 pollen seasons requiring intake of symptomatic treatment.
- Sensitization to birch pollen demonstrated by a positive Skin Prick Test to birch pollen with wheal diameter > 3 mm and birch pollen allergens specific IgE levels ≥ 0.70 kU/L.
- RRTSS based on the previous or on the penultimate birch pollen season ≥ 12 out of a maximum possible score of 18.
- Patients with an FEV1 (Forced Expiratory Volume at one second) ≥ 80% of the predicted value.
- Patients who are willing to comply with the protocol.
- Patients having given a signed informed consent before completing any study related procedure.
- Patients with symptoms of rhinitis/rhinoconjunctivitis during the birch pollen season due to any other allergens (except alder and hazel). This includes patients with symptomatic allergic rhinitis/rhinoconjunctivitis due to cat or dog allergens, and living with these animals at home or at risk of frequent contacts with these animals (family, friends etc.) during the course of the study.
- Patient who previously received desensitization treatment to birch pollen and/or another Betulaceae sp. (for example hazel or alder) within the previous 5 years.
- Patients with ongoing treatment by immunotherapy with another allergen.
- Pregnancy (positive pregnancy test), breast-feeding.
- Female patients of childbearing potential planning a pregnancy during this study or not using a medically accepted contraceptive method (hormonal birth control [orally, injectable or by implant, for at least 2 months before enrolment], intrauterine device, spermicide used with a male condom, bilateral tubal ligation, diaphragm with spermicide, female condom, monogamous relationship with a vasectomised partner).
- Patients planning to move during the study or planning to leave the area during the birch pollen season for more than 1 week (7 consecutive days).
- Patients with moderate or severe persistent asthma (GINA 3 or 4).
- Patients with seasonal mild persistent asthma (GINA 2) necessitating treatment with inhaled glucocorticosteroids at a dose level greater than 400 mcg budesonide dose-equivalents.
- Patients with any nasal or oral condition that could interfere with the efficacy or safety assessments (such as nasal polyposis or oral inflammation).
- Patients with severe immune deficiency.
- Patients with a past or current disease, which as judged by the Investigator, may affect the patient's participation in or outcome of this study.
- Any other disease or condition which would place a patient at undue risk by being included in the study (according to the Investigator's opinion).
- Usual contra-indications of immunotherapy such as concomitant beta-blocker therapy whatever the route and/or immunosuppressive drugs.
- Patients treated with inhaled/systemic steroids (whatever the indication) within 4 weeks prior to Visit 1 (Screening), or with long acting systemic corticosteroids 12 weeks before Visit 1 (Screening).
- Patients under continuous corticotherapy (inhaled or systemic drugs).
- Patients following a strict low sodium diet as the study treatment contains 590 mg of sodium chloride per vial in a 10 mL solution.
- Investigators, co-Investigators, as well as their children or spouses and all study collaborators.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo sublingual solution Birch pollen allergen extract Birch pollen allergen extract Sublingual Solution of Birch pollen allergen extract 300IR once daily 5 months per year and during 2 years
- Primary Outcome Measures
Name Time Method Average Adjusted Symptom Score Year 2 of treatment Symptom score adjusted on patient's rescue medication usage
- Secondary Outcome Measures
Name Time Method Oral Provocation Test Year 2 of treatment Analysis on a subset of patients presenting an Oral Allergy Syndrome at study entry
Mucosa Local Inflammation Year 1 of treatment Analysis on a subset of patients
Average Rhinoconjunctivitis Total Symptom Score Year 2 of treatment Average Rescue Medication Score Year 2 of treatment Each of Six Individual Average Rhinoconjunctivitis Symptom Scores Year 2 of treatment Average Combined Score Year 2 of treatment Average Rhinoconjunctivitis Visual Analogue Scale Score Year 2 of treatment Average Adjusted Visual Analogue Scale Score Year 2 of treatment Rescue Medication Usage Year 2 of treatment Proportion of Symptom-controlled Days Year 2 of treatment Rhinoconjunctivitis Quality of Life Questionnaire Year 2 of treatment Global evaluation of the efficacy by the patient Year 2 of treatment Sensitization profile Before and after each treatment period (over 2 years) sensitization profile (mono- vs poly-sensitized) is derived from the skin prick test results
Asthma Before, during and after each pollen season (over 2 years) Immunological markers specific for birch pollen Before and after each treatment period (over 2 years) Economical Evaluation Year 2 of treatment Proportion of days-off due to birch pollen-induced symptoms
Wheal diameter of the birch allergen Skin prick test Before and after each treatment period (over 2 years) Safety assessments ~20 months adverse events, physical examination including vital signs and laboratory data described by number of patients in each treatment group
Average adjusted Symptom score analysis by tertiles Year 2 of treatment
Trial Locations
- Locations (11)
Alergologicka ordinace
🇨🇿Plzen, Czech Republic
Merekivi Perearstid OÜ
🇪🇪Tallinn, Estonia
SPZOZ Uniwersytecki Szpital Kliniczny Nr 1im.N.Barlickiego w Uniwersystetu Medycznego w Łodzi
🇵🇱Lodz, Poland
National University Hospital - Allergy Unit 4222
🇩🇰Copenhagen, Denmark
NHC, Hôpitaux Universitaires de Strasbourg
🇫🇷Strasbourg, France
Helsingin yliopistollinen keskussairaala
🇫🇮Helsinki, Finland
Universitätsmedizin Berlin - Allergie-Centrum-Charité
🇩🇪Berlin, Germany
Centre of Investigations and Treatment of Allergic Diseases
🇱🇻Riga, Latvia
Imunologicko-alergologicka amb.
🇸🇰Banska Bystrica, Slovakia
Allergic Diseases Diagnostics and Treatment Centre
🇱🇹Vilnius, Lithuania
Sahlgrenska Universitetssjukhuset - Avd för Lungmedicin och Allergi
🇸🇪Göteborg, Sweden